IP Library Granted Patent US 11,865,344
Granted Patent B2
US 11,865,344 · App. 16/705,043 · Granted Jan 9, 2024

Neurostimulation titration process via adaptive parametric modification

Inventors: Imad Libbus (St. Paul, MN); Bruce H. KenKnight (Maple Grove, MN); Badri Amurthur (Los Gatos, CA); Scott R. Stubbs (Maple Grove, MN)
Assignee: LivaNova USA, Inc.
A61N1/36139A61B5/349A61N1/0551A61N1/3615A61N1/36114A61N1/36132A61N1/36167A61N1/3702A61N1/37223A61N1/37235G16H20/30G16H20/40G16H40/20G16H40/63G16Z99/00
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Quick Facts
Patent No.
US 11,865,344
App. No.
16/705,043
Granted
Jan 9, 2024
Kind
B2
Abstract

Systems and methods are provided for delivering neurostimulation therapies to patients. A titration process is used to gradually increase the stimulation intensity to a desired therapeutic level. Between titration sessions one or more parameters, such as, for example, an acclimation interval, may be adjusted based on the patient's response to the stimulation. This personalized titration process can minimize the amount of time required to complete titration so as to begin delivery of the stimulation at therapeutically desirable levels.

Claims (54)

1. A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, comprising:

delivering neurostimulation to a patient by the IMD, the neurostimulation comprising a plurality of stimulation parameters;

automatically increasing an intensity of the neurostimulation by an increment by modifying at least one of the stimulation parameters and delivering the neurostimulation according to the increased intensity over an acclimation interval, the acclimation interval comprising a period of time;

repeating automatically increasing the intensity and delivering the neurostimulation according to the increased intensity;

receiving, from an external control device, a first input from the patient indicating intolerance to the neurostimulation;

in response to receiving the first input from the patient, modifying at least one of the stimulation parameters to decrease the intensity of the neurostimulation;

subsequent to modifying the at least one of the stimulation parameters to decrease the intensity of the neurostimulation, receiving, from the external control device, a plurality of additional inputs from the patient indicating intolerance to the neurostimulation; in response to receiving the plurality of additional inputs from the patient, increasing the acclimation interval;

determining that the acclimation interval has reached a maximum acclimation interval; and

in response to determining that the acclimation interval has reached the maximum acclimation interval, modifying at least one different stimulation parameter to decrease the intensity of the neurostimulation.

2. The method of claim 1 , wherein the stimulation parameters comprise current amplitude, pulse width, frequency, and duty cycle.

3. The method of claim 2 , wherein modifying the at least one of the stimulation parameters to decrease the intensity of the neurostimulation comprises decreasing at least one of the current amplitude or the pulse width.

4. The method of claim 1 , wherein modifying at least one of the stimulation parameters to decrease the intensity of the neurostimulation comprises modifying at least one first stimulation parameter to decrease the intensity of the neurostimulation; and

wherein the method further comprises, in response to receiving the plurality of additional inputs from the patient, modifying at least one second stimulation parameter to decrease the intensity of the neurostimulation, the at least one second parameter being different from the at least one first parameter.

5. The method of claim 1 , further comprising receiving, from an external programmer, a prescribed time window during which the intensity of the neurostimulation is increased, the prescribed time window excluding a period during which the patient is likely sleeping.

6. The method of claim 1 , wherein the external control device is a patient magnet.

7. The method of claim 1 , further comprising modifying the increment based on a response of the patient to the neurostimulation.

8. A medical device for delivering neurostimulation comprising:

an implantable neurostimulator configured to couple to an electrode assembly, the neurostimulator configured to:

deliver neurostimulation to a patient, the neurostimulation comprising a plurality of stimulation parameters;

automatically increase an intensity of the neurostimulation by a increment by modifying at least one of the stimulation parameters and deliver the neurostimulation according to the increased intensity over an acclimation interval, the acclimation interval comprising a period of time;

repeat automatically increasing the intensity and delivering the neurostimulation according to the increased intensity;

receive, from an external control device, a first input from the patient indicating intolerance to the neurostimulation;

in response to receiving the first input from the patient, modify at least one of the stimulation parameters to decrease the intensity of the neurostimulation;

subsequent to modifying the at least one of the stimulation parameters to decrease the intensity of the neurostimulation, receive, from the external control device, a plurality of additional inputs from the patient indicating intolerance to the neurostimulation;

in response to receiving the plurality of additional inputs from the patient, increase the acclimation interval;

determine that the acclimation interval has reached a maximum acclimation interval; and

in response to determining that the acclimation interval has reached the maximum acclimation interval, modify at least one different stimulation parameter to decrease the intensity of the neurostimulation.

9. The medical device of claim 8 , wherein the stimulation parameters comprise current amplitude, pulse width, frequency, and duty cycle.

10. The medical device of claim 9 , wherein the neurostimulator is configured to modify the at least one of the stimulation parameters to decrease the intensity of the neurostimulation by decreasing at least one of the current amplitude or the pulse width.

11. The medical device of claim 8 , wherein the neurostimulator is configured to:

modify the at least one of the stimulation parameters to decrease the intensity of the neurostimulation by modifying at least one first stimulation parameter to decrease the intensity of the neurostimulation; and

in response to receiving the plurality of additional inputs from the patient, modify at least one second stimulation parameter to decrease the intensity of the neurostimulation, the at least one second parameter being different from the at least one first parameter.

12. The medical device of claim 8 , wherein the neurostimulator is further configured to receive, from an external programmer, a prescribed time window during which the intensity of the neurostimulation is increased, the prescribed time window excluding a period during which the patient is likely sleeping.

13. The medical device of claim 8 , further comprising the external control device, wherein the external control device is a patient magnet.

14. The medical device of claim 8 , wherein the neurostimulator is further configured to modify the increment based on a response of the patient to the neurostimulation.

15. A system comprising:

a processor; and

a memory storing instructions that are executable by the processor to:

deliver neurostimulation to a patient, the neurostimulation comprising a plurality of stimulation parameters;

automatically increase an intensity of the neurostimulation by a increment by modifying at least one of the stimulation parameters and deliver the neurostimulation according to the increased intensity over an acclimation interval, the acclimation interval comprising a period of time;

repeat automatically increasing the intensity and delivering the neurostimulation according to the increased intensity;

receive, from an external control device, a first input from the patient indicating intolerance to the neurostimulation;

in response to receiving the first input from the patient, modify at least one of the stimulation parameters to decrease the intensity of the neurostimulation;

subsequent to modifying the at least one of the stimulation parameters to decrease the intensity of the neurostimulation, receive, from the external control device, a plurality of additional inputs from the patient indicating intolerance to the neurostimulation;

in response to receiving the plurality of additional inputs from the patient, increase the acclimation interval;

determine that the acclimation interval has reached a maximum acclimation interval; and

in response to determining that the acclimation interval has reached the maximum acclimation interval, modify at least one different stimulation parameter to decrease the intensity of the neurostimulation.

16. The system of claim 15 , wherein the stimulation parameters comprise current amplitude, pulse width, frequency, and duty cycle.

17. The system of claim 16 , wherein the instructions are executable by the processor to modify the at least one stimulation parameter to decrease the intensity of the neurostimulation by decreasing at least one of the current amplitude or pulse width.

18. The system of claim 15 , wherein the instructions are executable by the processor:

to modify at least one of the stimulation parameters to decrease the intensity of the neurostimulation by modifying at least a first stimulation parameter to decrease the intensity of the neurostimulation; and

in response to receiving the plurality of additional inputs from the patient, modify at least a second stimulation parameter to decrease the intensity of the neurostimulation, the second parameter different from the first parameter.

19. The system of claim 15 , wherein the instructions are further executable by the processor to receive, from an external programmer, a prescribed time window during which the intensity of the neurostimulation is increased, the prescribed time window excluding a period during which the patient is likely sleeping.

20. The system of claim 15 , wherein the instructions are further executable by the processor to modify the increment based on a response of the patient to the neurostimulation.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2021
From: ACF FINCO I LP
To: LIVANOVA USA, INC.
Reel/Frame 057552/0378 →
SECURITY INTEREST Recorded Aug 16, 2021
From: LIVANOVA USA, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 057188/0001 →
RELEASE OF SECURITY INTEREST Recorded Aug 16, 2021
From: ARES CAPITAL CORPORATION, AS AGENT FOR THE LENDERS
To: LIVANOVA USA, INC.
Reel/Frame 057189/0001 →
PATENT SECURITY AGREEMENT Recorded Dec 30, 2020
From: LIVANOVA USA, INC.
To: ACF FINCO I LP, AS COLLATERAL AGENT
Reel/Frame 054881/0784 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: LIVANOVA USA, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 053673/0675 →